Events

Rapid Exchange Dilatation Balloon Catheter 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Medtronic Ireland || Medtronic Mexico, S. De R. L. De C. V. || Medtronic Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    R1707-313
  • 사례 연번
    2014DM-0012302
  • 날짜
    2017-07-31
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=77
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The importer has identified that in the referenced devices it may be difficult to remove the stylet, in such case, there is a possibility that the balloon or the catheter could be damaged due to the application of excessive force, so that it could be difficult to inflate or deflate the balloon, leading to possible adverse events on the patient or delays in the procedures.

Device

Rapid Exchange Dilatation Balloon Catheter
  • 모델명 / 제조번호(시리얼번호)
    Euphora and Solarice, lots 212553130 to 213283557.
  • 제품 설명
    The dilatation balloon catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in order to improve myocardial perfusion. The dilatation balloon catheter is also indicated for post-deployment expansion of expandable balloon stents.
  • Manufacturer
    Medtronic Ireland || Medtronic Mexico, S. De R. L. De C. V. || Medtronic Inc

Manufacturer

Medtronic Ireland || Medtronic Mexico, S. De R. L. De C. V. || Medtronic Inc
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NIDFSINVIMA